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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00457249
Other study ID # TD515
Secondary ID
Status Completed
Phase Phase 4
First received April 5, 2007
Last updated September 17, 2012
Start date March 2007
Est. completion date November 2008

Study information

Verified date September 2012
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

It is well recognized that older adults can contract pertussis, suffer its complications, and unwittingly transmit it to close contacts, which may well include infants too young to have received their primary series of DTaP vaccinations. ADACEL® vaccine is currently licensed in the US for persons 11 - 64 years of age, but no pertussis vaccine is yet approved for administration to older adults. The most widely used Td vaccine in the US, DECAVAC®, has no upper limit on its age indication.

The purpose of this trial is to describe the safety and immunogenicity of ADACEL® vaccine among individuals ≥ 65 years of age.


Recruitment information / eligibility

Status Completed
Enrollment 1564
Est. completion date November 2008
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria :

- Ambulatory and not institutionalized.

- At least 65 years of age at the time of vaccination.

- Signed Institutional Review Board (IRB)-approved informed consent form.

- Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria :

- Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.

- Serious chronic disease (eg, cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) that is unstable or that, in the opinion of the investigator, might:

- interfere with the ability to participate fully in the study; or

- interfere with evaluation of the vaccine.

- Known or suspected impairment of immunologic function, including use of immune suppressive medications (eg, rheumatoid arthritis drugs such as methotrexate; cancer chemotherapy agents such as vincristine).

- Febrile illness within the last 72 hours or an oral temperature = 100.4°F (= 38°C) at the time of inclusion.

- Any history of documented tetanus, diphtheria or pertussis disease.

- Known or suspected receipt of a tetanus, diphtheria or acellular pertussis containing vaccine within the preceding 5 years.

- Administration of immune globulin or other blood products within the last three months, or systemic corticosteroid therapy (prednisone or equivalent) for more than 2 consecutive weeks within the past 6 months.

- Systemic antibiotic therapy within the 72 hours prior to enrollment.

- Received any vaccine, other than influenza vaccine, in the 30-day period prior to enrollment or scheduled to receive any vaccine, other than influenza vaccine, in the 35-day period after enrollment. For influenza vaccine only, defer if received in the 14-day period prior to enrollment or scheduled to receive in the 14-day period after enrollment.

- Suspected or known hypersensitivity to any of the vaccine components.

- Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.

- Use of alcohol or drugs in a manner that may, in the opinion of the investigator, interfere with the subject's ability to comply with trial visits or procedures.

- Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.

- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent, or requires a legally authorized representative.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
0.5 mL, IM
DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed
0.5 mL, IM

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (Temperature), Headache, Myalgia, and Malaise. Day 0 up to 14 days post-vaccination No
Primary Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine Day 35 post-vaccination No
Primary Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations =0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®. Seroprotection was defined as a post-vaccination Concentrations of =0.10 IU/mL. Day 35 post-vaccination No
Primary Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine. Booster response was defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times, if pre-vaccination concentration is above the the cutoff value (Tetanus 5.47 IU/mL; Diphtheria 1.28 IU/mL) or at least 4 times it it is at or below the cutoff value. Day 35 post-vaccination No
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